Mandibular Stability and Dentofacial Deformity
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Purpose
The present study intends to clarify whether there is positional mandibular stability in patients to be submitted to orthognathic surgery. In case of any instability exists, it is needed to understand if this could be related to a particular type of dentofacial deformity or could have any short-term or long-term influence on outcomes of the orthognathic surgery.
| Condition |
|---|
|
Maxillofacial Abnormalities |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Evaluation of the Perioperative Mandibular Positional Stability in Subjects With Dentofacial Deformity |
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Dentofacial Deformity
Patients with dentofacial deformities candidate to orthognathic surgery
|
Detailed Description:
Treatment of skeletal discrepancy nowadays is mainly performed by combination of clinical and surgical procedures in which orthodontics intends to align the teeth according to their respective alveolar bone and the surgical procedure - orthognathic surgery - realign the jaws in an adequate position among themselves and related to the rest of the craniofacial skeleton. Orthognathic surgery has developed throughout the years technically as well as regarding fixation devices for the operated segments, providing prediction of results with a low complication incidence. A debate point is related to the possible instability of the mandibular position as a reference for surgical planning due to its articulation with the temporal fossa, the temporomandibular joint. However, studies have shown that not always the mandible position obtained for the articulator reflects the position observed in subjects after induction of general anesthesia. Since there is no evidence that indicates that any alteration of the position of the mandible could influence the outcomes of a orthognathic surgery nor any relationship of a certain type of dentofacial deformity that would be beneficiated by an specific order of surgery or skeletal reference (maxilla or mandible), the present study intends to clarify some of these questions.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Data will be obtained from subjects to be submitted to orthognathic surgery by the Department of Oral & Maxillofacial Surgery of the Hospital Geral Universitário of the city of Cuiabá - Brazil during the period of March 2012 through March 2013. Considering the local demand, thirty subjects are expected to be included in the research.
Inclusion Criteria:
- Dentofacial Deformity candidate to orthognathic surgery;
- Systemically capable to be submitted to the orthognathic surgery.
Exclusion Criteria:
- Patient's health condition is not stable enough to guarantee uneventful outcome;
- Required data unable to be achieved;
- Patient not agreeing to participate to the study.
Contacts and Locations| Contact: Alexandre M Borba, DDS, MSc | 55-65-9289-5924 | alex80@terra.com.br |
| Brazil | |
| Hospital Geral Universitario | Recruiting |
| Cuiaba, Mato Grosso, Brazil, 78000-000 | |
| Contact: Alexandre M Borba, DDS, MSc 55-65-3365-7150 | |
| Principal Investigator: Alexandre M Borba, DDS, MSc | |
| Principal Investigator: | Alexandre M Borba, DDS, MSc | University of Sao Paulo |
More Information
Publications:
| Responsible Party: | Alexandre Meireles Borba, Principal Investigator - PhD Student in Oral and Maxillofacial Surgery, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01486069 History of Changes |
| Other Study ID Numbers: | FOUSP - PhD Surg - 01 |
| Study First Received: | December 2, 2011 |
| Last Updated: | August 5, 2012 |
| Health Authority: | Brazil: Ethics Committee (Plataforma Brasil- Ministério da Saúde) |
Keywords provided by University of Sao Paulo:
|
Dentofacial Deformity Orthognathic Surgery Mandible Orthognathic Surgical Procedures |
Additional relevant MeSH terms:
|
Congenital Abnormalities Maxillofacial Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities |
Musculoskeletal Diseases Stomatognathic System Abnormalities Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013